Invokana Linked To Serious Side Effects
Janssen Pharmaceuticals’ Invokana (canagliflozin) was approved by the U.S. Food and Drug Administration (FDA) in 2013. As the first in a new class of diabetes drugs called active inhibitors of sodium-glucose co-transporter-2 (SGLT2), Invokana is intended to treat type 2 diabetes, along with diet and exercise. Invokana is thought to work by blocking glucose reabsorption into the bloodstream, thereby increasing urinary glucose excretion, and, in turn, lowering blood sugar levels in persons with elevated blood sugar concentrations. However, Invokana and SGLT2 inhibitors have been linked with serious medical conditions that could result in hospitalization or even death. Complications Associated with Invokana and the SGLT2 Inhibitors In 2014, Janssen Pharmaceuticals received FDA approval for another SGLT2 inhibitor, Invokamet, which combines Invokana and another type 2 diabetes drug, metformin. Together, Invokana and Invokamet accounted for more than $1.3 billion in Janssen worldwide sales in 2015. But Invokana, Invokamet, and the other SGLT2 inhibitors have been the subject of attention from government agencies in the U.S., Canada, Europe, and other countries because of serious medical complications. These conditions include: Diabetic ketoacidosis (DKA) – a condition involving too much acid in the blood that can result in coma, kidney and other organ injury, and death Serious urinary tract infections (UTIs) resulting in blood or kidney infections Acute kidney injury (AKI) Increased risk of leg, foot, and toe amputations (Invokana and Invokamet) If you have developed any of these conditions after taking Invokana or Invokamet, or if a relative died from one of these conditions while on these drugs, you may be entitled to reimbursement for medical expenses, lost wages, and Continue reading >>
What Is Invokana Diabetes Drug Dosage?
What is Invokana? Invokana (also known as canagliflozin) is an oral drug that is used to control blood sugar levels in people with Type 2 diabetes. It belongs to a group of medicines known as sodium glucose co-transporter 2 inhibitors or (SGLT2 inhibitors). People who have high levels of blood sugar can develop health complications in future. The drug is used with exercise and diet to help control high blood sugar levels, which can prevent health complications like kidney failure, loss of limbs and blindness. When diabetesis properly managed, it will reduce the risk of contracting cardiovascular disease such as heart attack and stroke. Canagliflozin works by increasing the removal of glucose by the kidney. It is important to note that this medicine cannot be used alone since it will not be as effective. Therefore, you should follow a diet and exercise program in addition to taking this drug. In case the diet or exercise is not adequate enough to control your blood glucose, this drug may be used to lower blood sugar in Type 2 diabetes. The drug is not used as a treatment for Type 1 diabetes. How does Canagliflozin work? This medication works by inhibiting SGLT2, which is a carrier that helps in the reabsorption of sugar into the bloodstream via the kidney. This occurs when blood is filtered out of the kidney into the urine. Invokana inhibits one of the transporters so that it can prevent sugar being reabsorbed back into the bloodstream. This will lead to excess sugar or glucose being excreted via urine. How to take this drug This medicine should be taken orally once every day. You can take the medication with food or on an empty stomach. However, Invokana is usually taken before the first meal of the day, since the drug effectively reduces blood sugar levels after meals. Continue reading >>
Invokana Diabetes Drug Litigation
In 2013, Johnson & Johnson introduced the diabetes drug Invokana to the market. Invokana was the first member of a new class of diabetes drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors—a drug designed to work by inhibiting some kidney functions to increase the amount of sugar excreted in urine. A little more than two years after Invokana’s introduction to the market, the U.S. Food and Drug Administration (“FDA”) issued a warning about serious risks associated with Invokana and other similar SGLT2 inhibitors. The FDA, in its May 2015 report, highlighted more than 20 adverse event reports linked to SGLT2 inhibitors, each of which resulted in hospitalization or emergency room treatment. Problems associated with Invokana include kidney failure, kidney impairment, kidney stones, urinary tract infections, and abnormal weight loss. The FDA has cautioned patients to be aware of the potential link between Invokana and diabetic ketoacidosis—a condition of high levels of acid accumulating in the blood. Difficulty breathing, nausea or vomiting, abdominal pain, confusion, fatigue and sleeplessness are all symptoms of ketoacidosis. Wexler Wallace represents individuals who are or have taken Invokana and experienced complications or side effects from taking the drug. If you or a loved one has suffered from diabetic ketoacidosis or experienced any adverse symptoms from taking Invokana, please contact us to speak to an attorney about your potential claim. Continue reading >>
Search Delicious, Diabetes-friendly Recipes
INVOKANA® can cause important side effects, including: Amputations. INVOKANA® may increase your risk of lower-limb amputations. Amputations mainly involve removal of the toe or part of the foot; however, amputations involving the leg, below and above the knee, have also occurred. Some people had more than one amputation, some on both sides of the body. You may be at a higher risk of lower-limb amputation if you: have a history of amputation, have heart disease or are at risk for heart disease, have had blocked or narrowed blood vessels (usually in leg), have damage to the nerves (neuropathy) in the leg, or have had diabetic foot ulcers or sores. Call your doctor right away if you have new pain or tenderness, any sores, ulcers, or infections in your leg or foot. Your doctor may decide to stop your INVOKANA® for a while if you have any of these signs or symptoms. Talk to your doctor about proper foot care Dehydration. INVOKANA® can cause some people to become dehydrated (the loss of too much body water), which may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). You may be at higher risk of dehydration if you have low blood pressure, take medicines to lower your blood pressure (including diuretics [water pills]), are on a low sodium (salt) diet, have kidney problems, or are 65 years of age or older Vaginal yeast infection. Women who take INVOKANA® may get vaginal yeast infections. Symptoms include: vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), or vaginal itching Yeast infection of the penis (balanitis or balanoposthitis). Men who take INVOKANA® may get a yeast infection of the skin around the penis. Symptoms include: redness, itching, or swelling o Continue reading >>
New Diabetes Drug Invokana Has Major Treatment - And Market - Potential
A new treatment option will soon be available to people with type 2 diabetes with the FDA's approval on Friday of Invokana, a first-in-class medication to lower blood sugar. Johnson & Johnson's Invokana (generic name canagliflozin) attacks blood sugar right from the get go, reducing the amount of sugar absorbed from food into the bloodstream. The body then flushes the excess sugar out in the urine. The medical profession - and analysts - have been paying close attention to Invokana because it lowers blood sugar by a different mechanism than the other diabetes drugs on the market. (Metformin, which I wrote about last week for its anti-cancer and anti-aging benefits, is one of the other popular diabetes medications available.) Controlling blood sugar is the key to preventing the many side effects caused by diabetes, such as vision loss, nerve damage, kidney damage, and increased risk of heart attack and stroke. Invokana has been subject to intense scrutiny and speculation because last year a similar drug, Forxiga (generic name dapagliflozin), developed by Bristol-Myers Squibb in partnership with AstraZeneca, was rejected by the FDA. The reason for the rejection was concern over liver damage and cancer risk, specifically breast cancer and bladder cancer. Howver, Forxiga was approved and is in use in Europe. Johnson & Johnson's application for Invokana cited nine clinical trials involving more than 10,000 patients. The main side effects found were urinary tract infections (UTIs) and yeast infections caused by large amounts of sugar in the urine. (Women prone to UTIs are familiar with this problem.) Forbes' Matthew Herper reports that this problem could limit Invokana's sales, according to some analysts' predictions. People taking Invokana were also found to have the potenti Continue reading >>
Invokana Side Effects Center
Invokana (canagliflozin) is a sodium-glucose co-transporter 2 (SGLT2) inhibitor used to control blood sugar in people with type 2 diabetes mellitus, in addition to diet and exercise. Common side effects of Invokana include: urinary tract infections, increased urination, yeast infections, vaginal itching, thirst, constipation, nausea, fatigue, weakness, skin sensitivity to sunlight, hypersensitivity reactions (including skin redness, rash, itching, hives, and swelling), bone fractures, and kidney problems. The recommended starting dose of Invokana is 100 mg once daily, taken before the first meal of the day. Doses may be increased to 300 mg in patients who are able to tolerate Invokana at 100 mg doses. Invokana may interact with rifampin or digoxin. Tell your doctor all medications you use. Invokana should only be given to a pregnant woman if the benefit of the drug justifies the risk of harm to the fetus. Breastfeeding women should decide with their doctors whether to breastfeed or to discontinue taking Invokana. Our Invokana (canagliflozin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Continue reading >>
What’s Invokana? 10 Things You Need To Know
Invokana (canagliflozin) is one of the new oral medications for adult onset diabetes. It’s expensive but has many upsides. Taken usually in combination with metformin it is a rising star in the treatment of diabetes. Here is what you need to know to help you decide: worth it or not? Invokana is taken as a 100 mg tablet once daily before breakfast, increasing to a 300 mg tablet once a day if you have normal kidney function. Invokana can be taken with or without food. Invokana is not yet recommended for use alone in the treatment of diabetes; it should be given as a second agent in addition to metformin or as a third-line treatment. Invokana works on the kidneys and tells the proximal tubule to resorb approximately 90 percent of the filtered glucose load. So, Invokana promotes dumping of glucose from the kidneys to the urine. Invokana used alone doesn’t lower blood sugars (measured by the A1C blood test) enough to make it effective as a single agent for diabetes. In studies it lowers A1C by 0.5 to 0.7 percentage points, making it a relatively weak glucose lowering agent. When should Invokana be added? It has been shown to be effective in lowering A1C when metformin alone is not achieving the goal A1C of < 7.0. Invokana 300 mg compared to Januvia 100 mg mixed with metformin was better at lowering blood sugar and helped with weight loss. Will I lose weight on Invokana? Yes, in most studies Invokana (used with metformin) resulted in a 6.5 pound weight loss at 12 weeks and an almost 10 pound weight loss at the end of a year. That’s quite a plus. The huge downside of Invokana is the frequency of genital fungal infections, which are almost sixfold higher. This means there is an increased risk of genital yeast infections: vulvovaginal candidiasis (vaginal yeast infections) Continue reading >>
Diabetes Drug Invokana Must Warn Patients About Increased Risk Of Foot, Leg Amputation
A new class of diabetes medicines is heavily advertised on TV and shows great promise in getting patients’ blood sugar levels down, but a safety announcement from the Food and Drug Administration warns that one of the drugs, Johnson & Johnson’s Invokana, doubles those patients’ chance of needing parts of their legs or feet amputated. People with diabetes are already at risk of having lower limbs amputated because of circulatory and nerve damage that the disease does over time. However, in two clinical trials of the drug canagliflozin, marketed as Invokana, Invokamet, and Invokamet XR, patients taking the drug were twice as likely to need amputations. Most of the amputations were of toes or the middle of the foot, but some patients needed their entire foot or leg removed, sometimes even above the knee. The two studies lasted a year. In one, which had 4,330 patients enrolled, 5.9 out of 1,000 patients treated with the drug needed amputations, compared to 2.8 out of 1,000 patients receiving a placebo. In the other, which enrolled 5,814 patients, 7.5 out of 1,000 patients receiving canagliflozin had a foot or leg amputation that year, compared to 4.2 out of 1,000 of the patients receiving a placebo. Due to these results, the FDA will require new warnings on Invokana, including the attention-getting boxed warning. It will alert patients to be watchful and notify health care providers about ulcers, infections, or any new pain or tenderness in their legs and feet. Physicians will be warned to consider an individual patient’s risk when deciding whether to prescribe the medication, including their past foot or toe amputations and history of diabetic ulcers, vascular disease, or nerve damage. Discovering serious risks from taking a drug after it’s been on the market isn Continue reading >>
Studies Show Diabetes Drug Invokana Increases Amputation Risk
People with diabetes who take a class of drugs known as sodium–glucose cotransporter 2 (SGLT2) inhibitors will now need to weigh benefits against risks after studies showed the medications significantly reduce heart problems in subjects, but, surprisingly, also increase the risk of amputation. The results of the studies on the Johnson & Johnson drug canagliflozin, marketed under the name Invokana, confirm cardiovascular benefits not only for that particular medication, but also for others in its class. Those same results, however, call into question whether other drugs in the class also contribute to increased amputation. “Drugs to treat diabetes have been undergoing a positive transformation in the last three or four years,” says Dr. Bruce Neal, lead investigator in the study and professor of medicine for University of New South Wales Sydney, and senior director, the George Institute for Global Health in Sydney, Australia. “It used to be we would test diabetes drugs to see if they lowered glucose levels and did not cause heart problems. Now, we test drugs and expect to see them not only lower glucose but improve cardiovascular health. It’s been extraordinary. But, now we might be finding out that there are glitches along the way.” Neal led a team of six other academic researchers combining data from two studies, the first a clinical trial before the drug was approved by the Food and Drug Administration in 2013 and the second a post-marketing study designed to detect any cardiovascular risks from the drug. Such studies are a recent requirement of the FDA to ensure safety of new medications across a wider population than may have been tested in clinical trials for the drug’s initial approval. The studies, one called Canagliflozin Cardiovascular Assessment S Continue reading >>
Invokana Lawsuit - Ketoacidosis & Kidney Injuries
About Invokana and SGLT2 Inhibitors The first SGLT2 inhibitor to be cleared for use in the U.S. was Invokana in 2012. SGLT2 inhibitors work differently than other diabetes medications as they don’t actually affect insulin levels. Instead, they limit the reabsorption of glucose in the kidneys to help reduce the amount of sugar in the bloodstream. Soon thereafter, in January 2014, the FDA approved Farxiga to treat Type-2 diabetes in adults when used in conjunction with diet and exercise. They allowed the drug into the marketplace with one caveat. Manufacturers Bristol-Myers Squibb and AstraZeneca had to conduct six post-market clinical studies, including a cardiovascular outcomes trial and a bladder cancer trial. The companies were also required to do studies on liver abnormalities, pediatric risks, urinary flow and pregnancy risks. Although finally approved to treat Type-2 diabetes in August 2014, Jardiance (empagliflozin) was originally denied FDA approval when initially submitted in March 2013. At that time, the FDA issued a letter referencing deficiencies at a Boehringer Ingelheim facility where empagliflozin would be manufactured and stated they needed to be resolved before the approval of the application. The FDA did not ask Boehringer to complete any new clinical trials to support the approval of the application. After less than one year on the market, the FDA issued a warning about the potential link between Jardiance and ketoacidosis. The approval of Invokamet, manufactured by Janssen Pharmaceuticals, also took place in August 2014. Invokamet is a combination of Invokana and Metformin hydrochloride, an older generation diabetes medication. It is intended to treat Type-2 diabetes in adults whose blood glucose is not adequately controlled by Metformin or Invokana Continue reading >>
Fda Adds "black Box" Warning To Popular Diabetes Drug Invokana
Following months of review of anecdotal and statistical evidence, the U.S. Food and Drug Administration has recently strengthened warnings on the packaging of one of the most popular drugs for the treatment of Type 2 diabetes. The medicine, canagliflozin is sold under the brand names Invokana, Invokamet and Invokamet XR. In theory, the medication helps diabetes patients better manage their insulin and blood sugar levels. In addition, it should prevent internal damage from diabetes symptoms. The medication was introduced for sale in 2013 and quickly became one of the most popular diabetes drugs on the market. Countless patients have taken Invokana since then in order to: Control blood sugar; Lower A1C levels; Prevent kidney damage often associated with diabetes; and Lower the risk of amputation caused by diabetes. (In some people, uncontrolled diabetes can cause circulatory issues, leading to infections, lack of blood flow, nerve damage and more.) Tragically, the very same drug that should have lowered patients' risk of diabetes-associated amputations may have caused them. Two large-scale clinical trials reviewed by the FDA in 2016 showed that people taking Invokana suffered amputations at nearly twice the rate of people given a placebo. The FDA advises that medical professionals use caution when prescribing Invokana, particularly if patients have risk factors for amputation. These include: History of prior amputation of limbs or digits; Vascular disease; Neuropathy; Diabetic-related foot ulcers; Delayed healing of wounds, particularly in the lower extremities; and Other serious diabetes-associated conditions (blindness, nerve damage, kidney damage, or heart disease). Were you prescribed Invokana to manage your Type 2 diabetes and suffered an amputation as a result? Or m Continue reading >>
Diabetes Drug Invokana And Amputation Risk
The U.S. Food and Drug Administration (FDA) informed manufacturing giant Johnson & Johnson in May, 2017 that they must put new warning labels on diabetes drug, Invokana (generic, canagliflozin), and its variations, Invokamet and Invokamet XR. The new warning is to alert the consumer to the clinical study findings that taking the diabetes drug can put them at double the risk of amputation of the leg and/or foot. The clinical studies, CANVAS and CANVAS-R were studies done by Johnson & Johnson that the manufacturer was counting on to show that Invokana was safe. The opposite was true and the drug had already had a past reputation for its side effects of diabetic ketoacidosis, bone fractures, heart attacks, strokes, in addition to the increased risk of amputations. For consumers taking Invokana, the FDA warns to look out for pain/tenderness, sores, ulcers, or infections in the leg and feet that are new since taking the drug. These conditions bring a much more significant chance of partial or total amputation and must be monitored carefully. If you or a loved one has been negatively impacted by Invokana, Invokamet, or Invokamet XR (or the generic form, canagliflozin), or other medical device, drug, or products, consult your medical provider and do not hesitate to contactInserra Kelley Sewell, Personal Injury Attorneys, to discuss your possible claim and entitlement to compensation for your damages. To learn more, visit: When it Comes to Invokana Diabetic Drug Lawsuits, We’re Fighting for Nebraskan’s Rights Continue reading >>
Invokana: Diabetes Drug Gets Black Box Warning For Amputation Risks
Invokana (canagliflozin), an SGLT-2 drug for use in type 2 diabetes and off-label in those with type 1 diabetes has been required by the FDA to carry the prominent boxed warning due to a higher risk for leg and foot amputations. This new requirement is a result of two clinical trials whose data revealed these elevated risks. Canagliflozin is the drug present in the marketed products: Invokana, Invokamet, and Invokamet XR. The clinical trials called CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) revealed that leg and foot amputations happened about twice as often in those taking canagliflozin compared to those taking a placebo. Over the span of a year the amputation risk for CANVAS trial patients was equal to 5.9 out of every 1,000 patients taking canagliflozin and 2.8 out of every 1,000 patients taking a placebo. Over the span of a year the amputation risk for CANVAS-R trial patients was equal to 7.5 out of every 1,000 patients taking canagliflozin and 4.2 out of every 1,000 patients taking a placebo. Most common was toe and middle the foot amputations but below and above the knee leg amputations were also observed. Some patients needed multiple amputations, “some involving both limbs.” This warning is in addition to last year’s FDA strengthened warning to users of canagliflozin for an increased risk of acute kidney injury and in 2015 the strengthened “warning for canagliflozin related to the increased risk of bone fractures,” Symptoms to Watch For The FDA warns that if you take Invokana (canagliflozin) you should be sure to call your healthcare provider immediately if you “develop new pain or tenderness, sores or ulcers, or i Continue reading >>
Invokana Lawsuit
Diabetes medications like Invokana (canagliflozin) have been linked to ketoacidosis and kidney injuries. Sodium-glucose cotransporter-2 (SGLT2) inhibitors are a group of drugs FDA-approved to treat low blood sugar in adults with Type 2 diabetes. The FDA has warned, however, that SGLT2 inhibitors like Invokana can lead to a condition known as diabetic ketoacidosis (DKA), characterized by excessive acid levels in the blood. The FDA has also warned about bone breaks and kidney injuries associated with SGLT2 inhibitors. A number of manufacturers—including Johnson & Johnson, which makes Invokana—sell diabetic medications that are associated with harmful side effects. Hundreds of lawsuits currently await trial against Invokana in federal and state courts. Plaintiffs argue that Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) misrepresented the risks of the medication and failed to warn patients about Invokana’s side effects. If you suffered an injury caused by Invokana or a similar SGLT2 inhibitor, you may be entitled to compensation. Contact us today for a free legal consultation. Serious Invokana Side Effects Invokana and similar drugs have strong links to ketoacidosis. There is also evidence that the drugs can cause impaired kidney function, heart problems, bone breaks, and other health complications. Ketoacidosis Symptoms of ketoacidosis, as noted by the American Diabetes Association, include: Trouble breathing Nausea Vomiting Abdominal pain Confusion or difficulty concentrating Unusual fatigue or sleepiness Dry or flushed skin Kidney Injuries Adverse event data has also pointed to possible impaired kidney function caused by Invokana and similar drugs. Adverse renal functions associated with these drugs include: Kidney failure Kidney impairment Dehydratio Continue reading >>
Diabetes Drug Invokana Makes Promising Progress
ST. LOUIS (KMOX) – A new drug shows promise in treating heart disease in diabetic patients. Type 2 diabetes drug Invokana significantly reduced the risk of serious heart problems in diabetics with heart disease, according to two new large studies. “Maybe we’re on the horizon of being able to not just treat blood sugars and help people kind of limp along, but maybe we’re on the horizon of actually really not having diabetes being such a devastating problem,” says SLU Care cardiologist Dr. Michael Lim at SSM Health SLU Hospital. Invokana reduced the combined risk of heart-related death, nonfatal heart attack and nonfatal stroke by 14 percent in diabetic patients and led to a reduced risk of hospitalization for heart failure and protected against kidney function decline. Continue reading >>
